OBJECTIVE: To compare health outcomes during 14-year observational follow-up in women initially randomised to unopposed estrogen or placebo. DESIGN: At recruitment to the Estrogen for the Prevention of Re-Infarction Trial (ESPRIT) women were assigned to estradiol valerate: 2 mg or placebo treatment for 2 years. SETTING:Women were recruited from 35 hospitals in the northwest of England and Wales in July 1996-February 2000. SAMPLE: Women aged 50-69 surviving their first myocardial infarction. METHODS: All women were followed by data linkage to UK mortality and cancer records; mean follow-up 14.1 and 12.6 years, respectively. In an intention-to-treat analysis, hazard ratios (HRs) were computed, overall and stratified by age at recruitment. OUTCOME MEASURES: Death (all-cause, cardiac disease, stroke or cancer) and cancer incidence (any, breast or endometrium). RESULTS:There were 418 deaths in 1017 women randomised. The all-cause mortality HR of 1.07 (95% CI 0.88-1.29) indicated no significant difference between treatment groups. Women aged 50-59 years at recruitment had lower HRs than women aged 60-69 years for all outcomes except ischaemic heart disease. Among 149 incident cancers there were seven cases of breast cancer in the intervention arm and 15 in the placebo; HR 0.47 (95% CI 0.19-1.15). There were no deaths from endometrial cancer but three incident cases, one in the active arm and two in placebo. CONCLUSIONS: These results suggest that unopposed estrogen may be used safely by women with an intact uterus surviving a first myocardial infarction.
RCT Entities:
OBJECTIVE: To compare health outcomes during 14-year observational follow-up in women initially randomised to unopposed estrogen or placebo. DESIGN: At recruitment to the Estrogen for the Prevention of Re-Infarction Trial (ESPRIT) women were assigned to estradiol valerate: 2 mg or placebo treatment for 2 years. SETTING:Women were recruited from 35 hospitals in the northwest of England and Wales in July 1996-February 2000. SAMPLE: Women aged 50-69 surviving their first myocardial infarction. METHODS: All women were followed by data linkage to UK mortality and cancer records; mean follow-up 14.1 and 12.6 years, respectively. In an intention-to-treat analysis, hazard ratios (HRs) were computed, overall and stratified by age at recruitment. OUTCOME MEASURES: Death (all-cause, cardiac disease, stroke or cancer) and cancer incidence (any, breast or endometrium). RESULTS: There were 418 deaths in 1017 women randomised. The all-cause mortality HR of 1.07 (95% CI 0.88-1.29) indicated no significant difference between treatment groups. Women aged 50-59 years at recruitment had lower HRs than women aged 60-69 years for all outcomes except ischaemic heart disease. Among 149 incident cancers there were seven cases of breast cancer in the intervention arm and 15 in the placebo; HR 0.47 (95% CI 0.19-1.15). There were no deaths from endometrial cancer but three incident cases, one in the active arm and two in placebo. CONCLUSIONS: These results suggest that unopposed estrogen may be used safely by women with an intact uterus surviving a first myocardial infarction.
Authors: Rowan T Chlebowski; Wendy Barrington; Aaron K Aragaki; JoAnn E Manson; Gloria Sarto; Mary J OʼSullivan; Daniel Wu; Jane A Cauley; Lihong Qi; Robert L Wallace; Ross L Prentice Journal: Menopause Date: 2017-02 Impact factor: 2.953
Authors: Rowan T Chlebowski; Thomas E Rohan; JoAnn E Manson; Aaron K Aragaki; Andrew Kaunitz; Marcia L Stefanick; Michael S Simon; Karen C Johnson; Jean Wactawski-Wende; Mary J O'Sullivan; Lucile L Adams-Campbell; Rami Nassir; Lawrence S Lessin; Ross L Prentice Journal: JAMA Oncol Date: 2015-06 Impact factor: 31.777